What are the water quality monitoring parameters for pharmaceutical process water?

Pharmaceutical water is a widely used auxiliary material in drug production. It is widely used in the drug production process and the preparation of pharmaceutical preparations. It is also used as a solvent, rinse agent, etc. The quality of pharmaceutical water directly affects the quality of drugs and is closely related to the safety of drugs. Pharmaceutical water can be divided into drinking water, purified water, water for injection, and sterile water for injection according to its different scope of use. There will be some differences in different countries. Pharmaceutical water should at least meet the requirements of drinking water. There are strict regulations and requirements on the design, installation, operation and maintenance of pharmaceutical water systems, as well as the preparation, storage and distribution of pharmaceutical water. So what parameters are specifically monitored for pharmaceutical water?

1. Conductivity
Conductivity is a physical quantity that characterizes the electrical conductivity of an object. Its value is the reciprocal of the resistivity of the object, and its unit is S/cm or μS/cm. Conductivity is a key quality attribute of pharmaceutical water, which is closely related to the purity of pharmaceutical water. The higher the purity, the smaller the conductivity. Conductivity can quickly monitor the total amount of electrolytes in pharmaceutical water, and can reflect the content of inorganic electrolytes such as chloride, sulfate, calcium salt, ammonia and carbon dioxide in the water. Therefore, the pharmacopoeias of various countries have clear regulations on the conductivity of pharmaceutical water. For example, Chp requires that the conductivity limit at 25°C is ≤5.1μS/cm. In addition, the conductivity is related to the pH and temperature of pharmaceutical water. In particular, temperature has a great influence on the measured value of conductivity. Since the results obtained by the temperature correction compensation method have large errors, non-temperature compensation mode is usually used, based on the actual temperature or adjustment. to the specified temperature, and determine the measurement conclusion based on the comparison between the measured conductivity value and the specified conductivity limit value corresponding to the temperature.

2.TOC
TOC is an indicator that characterizes the content of organic pollutants in pharmaceutical water. TOC and conductivity have become important indicators for water quality control and rapid monitoring. Compared with COD, BOD and other methods, TOC can more accurately, directly and comprehensively reflect the content of total organic matter in water. Organic substances in pharmaceutical water mainly come from water sources, water supply systems, and the growth of bacterial films in water systems. A lower level of TOC value means that organic matter, microorganisms and bacterial endotoxin contamination in the water are well controlled. Some current standards have a TOC control limit of 0.5mg/L.

3. Microorganisms
During the preparation, storage and use of pharmaceutical water, it is easily contaminated by microorganisms. Microorganisms and their metabolites can seriously affect drug safety, and the water system is relatively complex. Therefore, pharmaceutical water must be based on the concept of risk management, and regular microbial testing controls must be formulated. Strategies to ensure the quality of pharmaceutical water and products.

In addition, in addition to the above three important monitoring parameters, pharmaceutical water will also monitor COD, turbidity, pH, chlorine dioxide, color and other indicators according to different standards. Pharmaceutical water directly affects the safety of drugs. Both domestic and foreign countries attach great importance to the quality control and supervision of pharmaceutical water. Therefore, when choosing water quality analysis instruments in this industry, you must pay attention to quality. Daruifuno focuses on the R&D and production of water quality analysis instruments. Its main products include pH ORP analyzer, conductivity analyzer, turbidity analyzer, COD analyzer, dissolved oxygen analyzer, ammonium analyzer, chlorine analyzer, etc. It also has related products in the pharmaceutical water process. If you would like to know more, please contact us.